December 3, 2014
Dr. Anna E. Mazzucco
Thank you for the opportunity to participate in this meeting. My name is Dr. Anna Mazzucco, and I am speaking on behalf of the Cancer Prevention and Treatment Fund. I received my Ph.D. in cell biology from Harvard Medical School, and I conducted post-doctoral research at the National Cancer Institute. Those are the perspectives I speak from today.
Our organization conducts research and shares information with health professionals, patients, and consumers.
We applaud the efforts of the EPA to protect the public from harmful chemicals in their food, water, air and products they use every day. We strongly support the agency’s efforts to test chemicals more efficiently, and with the best possible scientific methods. Research has implicated endocrine-disrupting chemicals in cancer, infertility, and other health problems. We must be able to quickly identify such agents in order to prevent them from entering our food and environment, and from affecting our health for generations to come.
Use of high-throughput technologies is critical to expediting chemical screening, and we support the agency in these efforts. However, we have several concerns regarding the high-throughput screening approach as described in the EPA White Paper. Specifically,
- The EPA needs to spell out more clearly how prioritizing will be decided using this screening approach. The program should explicitly prioritize compounds based on risk contexts, such as those with widespread and persistent exposure profiles, and those with the most serious potential health effects.
- We know that chemical exposures during sensitive periods such as prenatal and adolescent development can greatly impact health in adulthood. These critical windows should be prioritized in bio-monitoring and population-based studies. This approach would protect the most vulnerable among us, and also ensure the greatest public health benefits for everyone.
- Other stakeholders have expressed concern over lack of clarity regarding the relationship between the area-under-the-curve model and potency as indicated by traditional assays. We are also concerned that the model has not been tested on a sufficiently diverse set of chemical structures. The agency needs to address these issues and provide additional evidence to support use of the current methodology, as opposed to other possible models.
- These screening assays must be relevant to real world exposures in order to be meaningful. Broad bio-monitoring and exposure studies are vital to informing extrapolation modeling in order to reap the benefits offered by high-throughput screening.
- As these high-throughput assays are further developed, the most orthogonal assays with the most downstream read-outs possible should be used, in order to capture the broadest possible range of mechanisms-of-actions.
- We agree with the EPA that metabolites could be missed using in vitro studies alone, and therefore some in vivo studies will be needed.
- We strongly urge the EPA to make the computational model fully accessible for independent assessment. That would increase transparency and stakeholder participation in this project.
Lastly, we share the concerns expressed in the Inspector General’s 2011 report that this process has not progressed as quickly as it should have. We strongly urge that adequate resources be dedicated to these efforts, in order that the agency may meet its goals in a timely fashion.
Thank you for the opportunity to address the panel today.